FDA Enforcement
Class II
Terminated
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135
Recall: Z-0296-2022
·
Reported December 1, 2021
Enforcement
- Recall Number
- Z-0296-2022
- Event ID
- 88962
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 1, 2021
- Initiation Date
- October 20, 2021
- Classification Date
- November 24, 2021
- Termination Date
- June 18, 2024
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418, United States
Description
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135
Reason
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Code Info
Serial Numbers: 124703 139012 139023
Distribution
US Nationwide Distribution
Quantity
3 units